Clinical trial
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of a BI 653048 BS H3PO4 Capsule Formulation Administered as Multiple Doses of 25 mg to 200 mg Once Daily (qd) for 3 Days Assessing Pharmacodynamics as Endotoxin-induced Inflammatory Response of a Single Intravenous Bolus Administration of 2 ng/kg Body Weight Lipopolysaccharide (LPS). A Randomised, Double-blind Within Dose Groups, Placebo-controlled, Multiple Rising Dose Phase I Trial With Open-label Active Comparator in Healthy Male Subjects
NCT02224105 is registered in ClinicalTrials.gov with Boehringer Ingelheim as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of a BI 653048 BS H3PO4 Capsule Formulation Administered as Multiple Doses of 25 mg to 200 mg Once Daily (qd) for 3 Days Assessing Pharmacodynamics as Endotoxin-induced Inflammatory Response of a Single Intravenous Bolus Administration of 2 ng/kg Body Weight Lipopolysaccharide (LPS). A Randomised, Double-blind Within Dose Groups, Placebo-controlled, Multiple Rising Dose Phase I Trial With Open-label Active Comparator in Healthy Male Subjects
- Lead sponsor
- Boehringer Ingelheim
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- March 31, 2010
- Completion date
- Not reported
- Enrollment
- 56 (actual)
- Sites
- Not reported
Conditions
As the registry lists them; a condition with its own page is linked.
healthy